A Study to Assess the Safety and Efficacy of LB1410 in Participants With Advanced Solid Tumor or Lymphoma（Keyplus-001）

NCT05357651 | Recruiting Phase 1

• 1 other identifier: LB1410-CHN-Ⅰ-01
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

This is a Phase I study designed to evaluate if experimental anti-PD-1 and anti-TIM-3 bispecific antibody, LB1410, is safe, tolerable and efficacious in participants with advanced solid tumors or lymphoma.

Conditions

Solid Tumor; Lymphoma

Outcome Measures

Primary Outcomes (4)

• Incidence and severity of treatment-emergent adverse events (TEAEs)

  According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0.

  up to 30 days following last dose.

• Incidence and severity of serious adverse events (SAEs)

  According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0.

  up to 90 days following last dose.

• AEs of special interest (immune-related AEs)

  Incidence and severity of immune-related AEs.

  up to 90 days following last dose.

• Incidence of DLTs

  The DLT for this study is defined according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0 and will be evaluated in the dose escalation part, the first 28 days (Cycle 1) of treatment.

  in the first 28 days (Cycle 1).

Secondary Outcomes (6)

• Serum PK parameters

  Up to finished treatment (each cycle is 28 days).

• Overall response rate (ORR)

  through study completion, an average of 8 months.

• Disease control rate (DCR)

  through study completion, an average of 8 months.

• Progression-free survival (PFS)

  through study completion, an average of 8 months.

• Duration of response (DOR)

  through study completion, an average of 8 months.

Study Arms (3)

Dose Escalation

EXPERIMENTAL

Up to 9 dose cohorts will be sequentially enrolled in the dose escalation part using an accelerated titration combined with the standard 3+3 dose escalation algorithm approach.

Drug: LB1410

Safety Expansion

EXPERIMENTAL

2-3 doses were initially selected for safety expansion, with patients with advanced solid tumors as the main research population. Each dose cohort is expected to enroll 9-12 patients.

Drug: LB1410

Exploratory Expansion

EXPERIMENTAL

The Cohort Exploratory Expansion will enroll subjects by cohort at the RP2D dose, and a total of 4 cohorts (cohorts A, B, C, D) are expected.

Drug: LB1410

Interventions

LB1410 DRUG

anti-PD-1 and anti-TIM-3 bispecific antibody

Dose Escalation; Exploratory Expansion; Safety Expansion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Must be ≥ 18 years of age
• For dose escalation and safety expansion phases only, patient must have histologically or cytologically confirmed advanced and/or metastatic solid tumor malignancies or lymphoma for which standard treatment fails, or no standard treatment is available, or standard treatment is not applicable at this stage
• Cohort A: NSCLC patients with histologically confirmed advanced or metastatic NSCLC who have previously failed anti-PD1/anti-PD-L1 antibody and platinum-based chemotherapy, and have not discontinued treatment due to AEs
• Cohort B: NSCLC patients with histologically confirmed advanced or metastatic NSCLC who have failed previous platinum-containing doublet chemotherapy but have not received PD1/PD-L1 antibody therapy；PD-L1 positive
• Cohort C: CRC patients with advanced colorectal cancer who have received no more than 2 lines of systemic therapy in the past; TIM-3≥10%
• Cohort D: Other advanced solid tumors patients who have received no more than two lines of systemic therapy, including but not limited to small cell lung cancer, endometrial cancer, anal cancer, ovarian cancer, head and neck squamous cell carcinoma, gastric adenocarcinoma or gastroesophageal junction cancer patients
• During the screening period, tumor tissue wax blocks or white slices of pathological biopsy sections shall be provided, or tumor tissue biopsy materials shall be allowed to be collected for PD-L1 and TIM-3 detection
• Eastern Cooperative Oncology Group Performance Status 0-1
• Patients with a life expectancy≥12 weeks
• Must have at least one measurable lesion for assessment by Response Evaluation Criteria in Solid Tumors (RECIST v1.1) or standard criteria for lymphoma (RECIL 2017)
• Adequate hematological and organ function measured within 7 days prior to first dose
• Non-pregnant women and willingness of female participants to avoid pregnancy or male participants willing to avoid fathering children through highly effective methods of contraception

You may not qualify if:

• Pregnancy, lactation, or breastfeeding
• Ongoing or recent (within 5 years) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments
• Treatment with anti-cancer therapy or investigational therapy within 28 days prior to the first dose of LB1410
• Patients who have used PD1 monoclonal antibody and TIM3 monoclonal antibody (both simultaneously or sequentially) in the past, and patients who have used one of them alone can be included
• Immunosuppressive corticosteroid doses (\>10 mg prednisone daily or equivalent) within 2 weeks prior to the first dose of LB1410
• Active infection , including known infection with human immunodeficiency virus (HIV), or active infection with hepatitis B HBV (HBV DNA\> 1000 copy/mL or 200 IU/mL) or hepatitis C virus (HCV)
• Previous malignant disease (other than the target malignancy to be investigated in this trial) within the last 3 years. Subjects with history of cervical carcinoma in situ, superficial, or non-invasive bladder cancer, or basal cell, or squamous cell cancer in situ or other in situ cancers previously treated with curative intent may be included at the judgment of Investigator
• History of documented allergic reactions or acute hypersensitivity reactions attributed to treatment with antibody therapies in general, or to any of the components of LB1410
• Symptomatic or uncontrolled brain metastases, spinal cord compression, or leptomeningeal disease requiring concurrent treatment, including but not limited to surgery, radiation, and/or corticosteroids (participants receiving anticonvulsants are eligible)
• Participant has not recovered (i.e., to \<= Grade 1 or Baseline) from radiation- and chemotherapy-induced AEs (except alopecia, peripheral neuropathy, and ototoxicity, which are excluded if ≥ CTCAE grade 3)
• History of organ transplantation
• Inadequate recovery from any prior surgical procedure or having undergone any major surgical procedure within 4 weeks prior to the study drug treatment
• Impaired cardiac function or clinically significant cardiac disease, including any of the following
• Interstitial lung disease or interstitial pneumonitis, including clinically significant radiation pneumonitis (i.e., affecting activities of daily living or requiring therapeutic intervention)
• Type 2 diabetes mellitus or type 2 diabetes patients with poor glycemic control.

Sponsors & Collaborators

• L & L Bio Co., Ltd., Ningbo, China: lead

Study Sites (1)

Shanghai Pulmonary Hospital

Shanghai, Shanghai Municipality, China

RECRUITING

MeSH Terms

Conditions

Lymphoma

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Caicun Zhou

  Shanghai Pulmonary Hospital, Shanghai, China

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yan Luan

CONTACT

+86-21-54152522; luanyn2@lnlbio.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 27, 2022
• First Posted: May 3, 2022
• Study Start: August 12, 2022
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2028
• Last Updated: September 11, 2025

Record last verified: 2025-09

Locations

CN (1)